Responding to growing fears of an avian influenza pandemic and threats of bioterrorism, the US Senate will consider legislation as early as this week to give the pharmaceutical and biotech industries new incentives to develop drugs and countermeasures against a range of pathogens, while offering vaccine manufacturers protection against liabilities.
Separately, President Bush yesterday (Nov. 1) outlined a $7.1-billion national strategy to expand domestic vaccine production capacity, detect and respond to influenza outbreaks, and stockpile treatments against the H5N1 avian influenza A virus, whose possible mutation into human transmissible form has sparked fears of a global pandemic.
Various biodefense measures are currently pending in Congress. Prominent among these is the Biodefense and Pandemic Vaccine and Drug Development Act (S. 1873). The bill, authored by Sen. Richard Burr (R-NC), would establish a new government agency -- the Biomedical Advanced Research and Development Agency (BARDA) -- to fund and coordinate government R&D efforts into countermeasures for bioterrorism and natural outbreaks. The bill would offer liability protection for vaccine manufacturers and a 10-year marketing exclusivity for companies producing countermeasures, during which time competitors could not produce generic substitutes.
While the new bill enjoys support from the brand-name drug and biotech industries and lawmakers from both parties, some generic drug manufacturers, consumer groups, and health care insurers say the exclusivity provisions will increase prescription drug costs. Some Democrats have also expressed concern that the bill provides too much immunity for vaccine manufacturers. "There are some concerns," acknowledged Burr spokesman Doug Heye, who said the senator plans to work with Democrats when the bill reaches the Senate floor.
But supporters defended the measure. "It's not a bailout," said Frank Rapoport, managing partner at McKenna Long & Aldridge, a law firm representing drug companies seeking government contracts. "Pharmaceutical companies can be sued if fraud was committed in the FDA application process. But otherwise companies and the government are immune from lawsuits," he said.
The bill, which passed the Health, Education, Labor, and Pensions (HELP) Committee Oct. 17 and is awaiting full Senate vote, assumes the place of "BioShield II" legislation introduced by Senators Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah) last year. BioShield II was a failed attempt to create industry incentives to support Project BioShield, the Administration's plan to purchase $5.6 billion in vaccines and drugs over 10 years. About $2.5 billion has already been earmarked for procurement.
Other biodefense measures pending in the Senate include an Oct. 27 amendment introduced by Democrats to provide nearly $8 billion in emergency spending to stockpile influenza antivirals, support vaccine R&D, and beef up the nation's surveillance and public health infrastructure.
"We must fund a crash program to help our best scientists bring the next generation of technology online rapidly," Bush said in a speech yesterday at the National Institutes of Health (NIH). As part of the emergency funding request for the avian flu, Bush is seeking $2.8 billion to develop cell-culture technologies to give companies the "surge capacity" to rapidly produce pandemic flu vaccines. The goal is to be able to produce enough vaccine for every American within six months of an outbreak by "bringing cell-culture technology from the research laboratory into the production line" by 2010, Bush said.
Citing the "growing burden of litigation," the president also urged Congress to pass liability protection to encourage vaccine manufacturers to return to this market. Of the dozens of vaccine manufacturers that existed years ago, only five major companies remain worldwide, one of which is based in the US. Officials did not disclose details of the administration's plan yesterday and said that Health and Human Services Secretary Michael O. Leavitt would provide more information today (Nov. 2).